Early Access Program - Kisqali / Ribociclib for EBC

cactusk

Hi there,
My medical oncologist called me yesterday to discuss the issues with the current early access program for early BC and Kisqali / Ribociclib. 
Apparently, the current formulation contains very small quantities of 'nitrosamine' which have been shown in studies to potentially (in a very small number of cases) cause another cancer.
The new formulation will not be available for a few months from the manufacturer.
Has anyone else who is on Ribociclib had this discussion with their med onc / decided to pause the drug - or decided that the risks are OK and chosen to continue with the medication?
Noting there is a BC conference in Berlin next week (my med onc is going but not presenting) and there are a number of sessions discussing CDK4/6 inhibitors for early BC with high likelihood of recurrence.
Not sure also if this affects mets patients who are on Ribociclib already too?
Just when I think I'm on a certain path things change ... again.
Kelly
(totally acknowledging personal choice etc - but keen to know what others have been told, and if anyone is OK to share, what they have decided to do).

Mez_BCNA

Hi @cactusk thankyou for your post. We wanted to jump in on this very important topic, as BCNA is aware of this and we are talking to the pharmaceutical company about it. Will will aim to provide an update as soon as possible

cactusk

Thanks @Mez_BCNA - sorry if I jumped the gun!
I'm keenly following this as I'm sure others are.

Mez_BCNA

Don't apologise @cactusk . You are here to create conversation, access information, provide support and be supported

Mez_BCNA

Hi @cactusk I have the below additional information from our policy & advocacy team. Please reach out if you need further clarification about the information provided:

Thank you for your post about changes relating to ribociclib for early breast cancer. This issue recently came to our attention and we have gathered some information for yourself and others reading this post as we appreciate the issue may be quite confusing.
Kind regards,

BCNA Policy & Advocacy team.

What are nitrosamines? Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. They can also be produced during the manufacturing of certain medications, particularly those containing specific ingredients or undergoing certain chemical reactions.  Everyone is exposed to some level of nitrosamines.

There are internationally recognized acceptable daily intake limits for nitrosamines. Regulatory authorities like the Food and Drug Administration (FDA), European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) continuously monitor and evaluate the safety of medicines, including their potential for nitrosamine levels. If new evidence emerges, or if safety concerns arise, these regulators may adjust their limits. In August 2023, the FDA lowered acceptable intake limits for nitrosamines in medications in the early breast cancer setting.

What is the issue with ribociclib?  Ribociclib contains a nitrosamine impurity that exceeds these new limits. To comply with the new guidelines, Novartis (the manufacturer) is required to make some manufacturing adjustments to ribociclib.

What is being done: Novartis is implementing manufacturing adjustments for ribociclib to ensure alignment with the latest regulatory standards, but it will take some months before it is available. Between now and the new product being available, no one will be able to commence taking ribociclib.

What do you need to do if you are currently taking ribociclib for early breast cancer? All clinicians in Australia with patients taking ribociclib have been advised about these changes. People already taking ribociclib for early breast cancer should consult with their healthcare provider as they are the best resource for personalized guidance and advice regarding medication safety and management.

What about other drugs used for early breast cancer? BCNA is not aware of any other breast cancer drugs being impacted by these changes at this time.

cactusk

Thanks @Mez_BCNA
Pretty much exactly as my med ond explained to me.
Appreciate the follow up.

PCK

Hi 
Just wondering it's been 5months since the issue on Kisqali, are you back on another CDK4/6 med or do we have new updates on Novatis releasing a new formula for it? @cactusk @Mez_BCNA

I'm on the path of determining of adding CDK4/6 to go with hormone therapy in the coming weeks as EBC myself. And, since I'm currently living and was diagnosed overseas, I'd like to know if these oral medications covered by medicare? As the cost of CDK4/6 is quite expensive in the country I'm in right now. 

Any info would be much appreciated x

cactusk

Hi @PCK
I stayed on the current formulation of Kisqali - but have just come off it due to liver problems.
I was on an early access program - it wasn't covered by Medicare, is very expensive but was only the standard script cost for me ($31.60).
I don't see my med onc till early November and will discuss then whether or not I go onto a differenct CDK4/6 inhibitor.
Let me know how you go - and best of luck.
Kelly